For Long Life, Swallow Anything: Part I
Dietary Supplement Health and Education Act
In a disquieting new book Dan Hurley discusses the safety and effectiveness of diet supplements, "Natural Causes: Death, Lies and Politics in America's Vitamin and Herbal Supplement Industry" (Broadway Books). Hurley's publication provides a penetrating and long-needed insight into the national health consequences of the Dietary Supplement Health and Education Act of 1994. While this bill forbade manufacturers to claim that their products "treat, cure or prevent" any disease, it allowed them to make vaguer claims based on a standard that in retrospect was nothing less than outrageous: the right to hype supplements; without requiring any kind of testing. In effect, the new law forbade the FDA from treating food supplements as drugs or food additives and allowed companies to continue making health claims without scientific backing.
According to Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest. "The consumers who wrote Congress had a financial interest in the matter or were duped into believing the FDA was using the new labeling law to ban their favorite vitamins... People should have the right to try any type of health care that they choose. But ... (should) manufacturers have the right to hype supplements on the basis of unreliable scientific information or downright false claims?" At the time of passage, the bill had been almost universally opposed, by long-time mainstream consumer and health organizations, including Consumers Union, Consumer Federation of America, Center for Science in the Public Interest, the American Association of Retired Persons, American Heart Association, the American Cancer Society, American Dietetic Association and the American College of Physicians.
History behind the Legislation
According to PR Watch the legislative story began in 1992 in Hollywood when dietary supplement makers engaged the PR firm Rogers & Cowan to help launch the Nutritional Health Alliance (NHA), a grassroots PR campaign designed to fight what it called "the FDA's bias against preventive medicine and the dietary supplement industry." Rogers & Cowan, whose clients include Microsoft, Baskin-Robbins ice cream, Nabisco foods and R.J. Reynolds are well-known for their connections with film studios and movie stars such as Ann Margret and Dustin Hoffman. It thus came as no surprise when the Nutritional Health Alliance campaign against the FDA enlisted Hollywood notables in their campaign. When a TV advertisement depicted mock FDA agents dressed in riot gear, raiding Mel Gibson's house and confiscating his vitamins, Gibson joined celebrities such as Whoopi Goldberg, Sissy Spacek, Laura Dern, Mariel Hemingway and Victoria Principal in making public service announcements claiming that the FDA was trying to block consumer access to vitamins. At the grassroots level, supplement makers turned to their multilevel marketing and sales organizations combined with the country's network of 10,000 health food stores and their customers, mobilizing supporters through millions of dollars in targeted advertising and flyers. One brochure by the NHA urged consumers to "write to Congress today or kiss your supplements goodbye."
As also reported by PR Watch, the goal of the (NHA) campaign was to ensure passage of the 1994 Dietary Supplement Health and Education Act (DSHEA), sponsored by Utah Senator Orrin S. Hatch, whose home state is a haven for multiple level marketers and supplement companies. The Utah Natural Products Association uses Parry & Romani Associates, a Washington lobby shop "whose connections offer a classic glimpse of Washington-style incestuous influence-peddling." This firm is headed by Thomas Parry, a former aide to Orrin Hatch, and who now raises campaign money for the Senator. The company also conveniently employs Scott Hatch, Orrin's son, who lobbies on behalf of clients such as the Non-Prescription Drug Manufacturers Association, and Herbalife International.
Nutritional Health Alliance and other supplement lobby groups are themselves closely tied in with a principal Washington lobbyist, Podesta Associates, headed by Anthony T. Podesta, a former aide to Massachusetts Senator Edward M. Kennedy, with Anthony's brother John .who served as staff secretary to President Clinton from 1993-95. A litany of other lobbyists, PR companies, and multiple interrelationships of an archipelago of industries with friends in high places of both major political parties is further described in breath-taking detail at the above link.
Safety and Standardization of Diet Supplements
Since 1983, the American Association of Poison Control Centers, a national association of state and local poison centers, has kept statistics and reports of poisonings for every type of substance including dietary supplements. According to Hurley "...by 2005. 125,595 incidents were reported related to vitamins, minerals, essential oils, herbs, and other supplements. In April 2004 the Food and Drug Administration (FDA) said it had received 260 reports of deaths associated with herbs and other non-vitamin, non-mineral food supplements, but an unpublished study in 2000 by Dr. Alexander Walker, of Harvard Medical School concluded that "...less than 1% of serious adverse reactions caused by dietary supplements are reported to the FDA."
According to the FDA "Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists in the United States for standardization as it applies to dietary supplements.... following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality." (My emphasis.)
The FDA, in all fairness, continues to monitor the safety of dietary supplements on this important site. "Warnings and Safety Information on dietary supplements, along with "Alerts" "Additional Safety Information," and "Reporting Problems" are noted extensively. A few examples include the following out of the hundreds listed:
Anthrax: Dietary Supplements Claiming to Prevent or Treat Anthrax November 7, 2001
FTC Federal Trade Commission, (Not the FDA) Cracks down on Marketers of Bogus Bioterrorism Defense Products
FDA Concerned About Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid
FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products
Hepatic Toxicity Possibly Associated with Kava-Containing Products
LipoKinetix: FDA Warns About Weight Loss Product
FDA alerts consumers and health care professionals about LipoKinetix, a dietary supplement weight loss product. This product has been implicated in a number of serious adverse reactions related to several cases of liver injury.
St. John's Wort and Indinavir
FDA Public Health Advisory: Risk of Drug Interactions with St. John's Wort and Indinavir and Other Drugs February 10, 2000
FDA Warns Consumers Against Consuming Dietary Supplements Containing Tiractricol
November 21, 2000
FDA Warns Consumers Not to Feed Infants "Better than Formula Ultra Infant Immune Booster 117", January 23, 2004
FDA Warns Public about Chinese Diet Pills Containing Fenfluramine, August 13, 2002
Tip of the Iceberg?
How much of this is temporizing by the FDA or mere Government double talk substituting for action? Thanks to the Dietary Supplement Act of 1994 the FDA is not empowered, as they are with drugs, to remove these poisons from the marketplace. But they can at least be Concerned, issue advisories, warnings, alerts, and report risks and adverse reactions.
For more on this, Stay Tuned.
Martin F. Sturman, MD, FACP
Copyright 2006, Mathemedics, Inc.
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